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Date Printed: December 18, 2017: 11:41 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

01-91000-07

Original Effective Date: 12/15/03

Reviewed: 09/21/09

Revised: 01/01/17

Subject: Transanal Radiofrequency Therapy as a Treatment of Fecal Incontinence

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Radiofrequency energy is a commonly used surgical tool used for tissue ablation and more recently for tissue remodeling. For example, radiofrequency energy has been investigated as a treatment of gastroesophageal reflux disease (GERD), i.e., the Stretta procedure, where radiofrequency lesions are designed to alter the biomechanics of the lower esophageal sphincter (see MCG 01-91000-03), in orthopedic procedures to remodel the joint capsule (see MCG 02-20000-23), or in intradiscal electrothermal annuloplasty (IDET) procedures where the treatment is intended in part to modify and strengthen the disc annulus (see MCG 02-61000-20). In all of these procedures, non-ablative levels of radiofrequency thermal energy are used to alter collagen fibrils, which then result in a healing response characterized by fibrosis. Recently, radiofrequency energy has been explored as a minimally invasive treatment option for fecal incontinence, referred to as the Secca procedure. The Secca™ System received FDA-approval in 2002 for general use in the electrosurgical coagulation of tissue and is intended for use specifically in the treatment of fecal incontinence in a select sub-set of individuals.plex.

POSITION STATEMENT:

Transanal radiofrequency therapy for the treatment of fecal incontinence is considered experimental or investigational, as the available clinical data are insufficient to determine effectiveness of this treatment.

BILLING/CODING INFORMATION:

There is no specific code for reporting transanal radiofrequency therapy.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

Fecal incontinence: the involuntary leakage of stool from the rectum and anal canal. Fecal continence depends on a complex interplay of anal sphincter function, pelvic floor function, stool transit time, rectal capacity, and sensation. There are a variety of causes for fecal incontinence, including injury from vaginal delivery, anal surgery, neurologic disease, and the normal aging process. It is estimated that the disorder affects some 8% of the adult population.

RELATED GUIDELINES:

Transendoscopic Therapies for Gastroesophageal Reflux Disease (GERD), 01-91000-03
Thermal Capsulorrhaphy as a Treatment of Joint Instability, 02-20000-23

Thermal Intradiscal Procedures (e.g., IDET, IDB, PIRFT), 02-61000-20

OTHER:

Indexing terms:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of
one product over another, and is not intended to represent a complete listing of all products available.

Fecal incontinence, radiofrequency treatment
Secca procedure
Secca™ System

REFERENCES:

  1. American College of Gastroenterology (ACG). Fecal Incontinence. Adil E. Bharucha, M.B.B.S., M.D., Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN (2006). Accessed 09/14/09.
  2. American College of Gastroenterology Practice Guidelines, Diagnosis and Management of Fecal Incontinence (2004). Accessed 09/14/09.
  3. American Society of Colon and Rectal Surgeons, press release “New Studies Reveal Benefits of Radiofrequency for Treatment of Fecal Incontinence” (04/01/02), Accessed 09/04/08.
  4. Blue Cross Blue Shield Association Medical Policy 2.01.58 – Transanal Radiofrequency Treatment of Fecal Incontinence (03/12/09).
  5. Curon supported Clinical Trial: Lahey Clinic Medical Center, Burlington; Treatment for Fecal Incontinence. Patricia L Roberts, MD. Accessed 10/20/03.
  6. Efron JE, Corman ML, Fleshman J, Barnett J, Nagle D, Birnbaum E, Weiss EG, Nogueras JJ, Sligh S, Rabine J, Wexner SD. Safety and effectiveness of temperature-controlled radio-frequency energy delivery to the anal canal (Secca procedure) for the treatment of fecal incontinence. Dis Colon Rectum. 2003 Dec; 46(12): 1606-16; discussion 1616-8. Comment in: Dis Colon Rectum. 2005 Jan; 48(1): 175; author reply 175-6.
  7. Efron JE. The SECCA procedure: a new therapy for treatment of fecal incontinence. Surg Technol Int. 2004; 13:107-10.
  8. National Association for Continence, Treatment Options for Incontinence (Accessed 09/14/09).
  9. National Digestive Diseases Information Clearinghouse (NDDIC), National Institute of Health (NIH) Publication No. 04-4866 (03/04) (Accessed 09/14/09).
  10. Takahashi T, Gardia-Osogobio S, Valdovinos MA, Belmonte C, Barreto C, Velasco L. Extended two-year results of radio-frequency energy delivery for the treatment of fecal incontinence (the Secca procedure). Dis Colon Rectum. 2003 Jun; 46(6): 711-5. (PubMed, Medline).
  11. Tjandra JJ, Dykes SL, Kumar RR, Ellis CN, Gregorcyk SG, Hyman NH, Buie WD, Standards Practice Task Force of The American Society of Colon and Rectal Surgeons. Practice parameters for the treatment of fecal incontinence. Dis Colon Rectum 2007 Oct; 50(10):1497-507.
  12. US Food and Drug Administration (FDA) 510(k) summary K014216 (03/21/02).

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 09/21/09.

GUIDELINE UPDATE INFORMATION:

12/15/03

New Medical Coverage Guideline Developed.

10/15/04

Scheduled review; no change in coverage statement.

01/01/06

Scheduled review; no change in coverage statement; updated references.

11/15/06

Scheduled review; no change in coverage statement; updated references.

08/15/07

Scheduled review; reformatted guideline; updated references.

11/15/08

Scheduled review; no change in position statement; updated references.

10/15/09

Scheduled review; no change in position statement; updated references.

01/01/12

Annual HCPCS coding update: added 0288T.

05/11/14

Revision: Program Exceptions section updated.

05/15/14

Revision; Program Exceptions section updated.

01/01/17

Annual CPT/HCPCS update. Deleted 0288T.

Date Printed: December 18, 2017: 11:41 AM